Objective: To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis.
Design: Randomized controlled trial.
Setting: Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.
Participants: 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized.
Interventions: 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression.
Main Outcome Measures: The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time.
Results: At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001).
Conclusions: This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional "simple" decompression and even showed a fairly high reoperation rate after interspinous process device implantation.
Trial Registration: Dutch Trial Register NTR1307.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3898636 | PMC |
| http://dx.doi.org/10.1136/bmj.f6415 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Longitudinal DTI analysis of microstructural changes in lumbar nerve roots following Interspinous process device placement.
Magn Reson Imaging
December 2024
Neurology Unit, Department of Neurology and Human Movement Sciences, University Hospital of Siena, Siena, Italy; Department of Medical, Surgical and Neurological Science, University of Siena, Siena, Italy. Electronic address:
Diffusion tensor imaging (DTI) and its parameters such as fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), radial diffusivity (RD) are increasingly being used to assess peripheral nerve integrity alongside nerve conduction studies. This pilot study aims to compare DTI values of lumbar spinal nerve roots before (T0) and after (T1) treatment with an interspinous process device (IPD). Seven patients (5 females, 2 males; mean age: 68) suffering from neurogenic claudication and lumbar spinal canal and foraminal stenosis were evaluated.
View Article and Find Full Text PDFHow Reliable is the Assessment of Fusion Status Following ACDF Using Dynamic Flexion-Extension Radiographs?
Global Spine J
December 2024
Department of Neurological Surgery, Weill Cornell Medicine, New York, NY, USA.
Study Design: Reliability study.
Objectives: The radiographic diagnosis of non-union is not standardized. Prior authors have suggested using a cutoff of <1 mm interspinous process motion (ISPM) on flexion-extension radiographs, but the ability of practicing surgeons to make these measurements reliably is not clear.
Multicenter External Validation of the Accuracy of Computed Tomography Criteria for Detecting Thoracolumbar Posterior Ligamentous Complex Injury.
Neurosurgery
December 2024
Altakassusi Alliance Medical, Riyadh, Saudi Arabia.
Background And Objective: Recent studies have proposed computed tomography (CT) criteria for posterior ligamentous complex (PLC) injury: disrupted if ≥2 CT findings, indeterminate if single finding, and intact if 0 CT findings. The study aims to validate the CT criteria for PLC injury externally.
Methods: Three level 1 trauma centers enrolled 614 consecutive patients with acute thoracolumbar fractures (T1-L5) who received CT and MRI.
Ewing Sarcoma of Left Thigh With Nodal, Paraspinal and Soft Tissue Metastatic Lesions: A Case Report.
Clin Med Insights Case Rep
November 2024
Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Introduction: Ewing sarcoma is a rare and highly aggressive malignancy, mostly involving the axial skeleton. Ewing sarcoma usually affects children and young adults under 20. Usually presenting as a painful swelling and discomfort worsening over time.
View Article and Find Full Text PDFEffect of Different Interventions on Lumbar Spinal Stenosis: A Systematic Evaluation and Network Meta-Analysis.
World Neurosurg
December 2024
Department of Spine and Orthopaedics, Wuhu Hospital of Traditional Chinese Medicine, Wuhu, Anhui, China. Electronic address:
Background: Surgery is the preferred option for lumbar spinal stenosis (LSS) when conservative methods cannot meet the needs. Recent advancements in surgical techniques have brought various new methods for treating LSS.
Methods: Four databases, PubMed, Embase, the Cochrane Library, and Web of Science, were searched, covering the period from the establishment of the databases until May 2024.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!